A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
Megadott ok: The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.
Key facts
- Where
- Atlanta, Aurora, Bethesda, Birmingham, Chapel Hill, Cleveland, Columbia, Durham, Grand Rapids, Gulf Breeze, Hollywood, Houston, Livingston, Los Angeles, Miami, New Hyde Park, New York, Pittsburgh, Rochester, San Diego, Seattle, Tacoma és Winter Park, Egyesült ÁllamokSee the 25 sites
- Phase
- 3. fázis
Where in Egyesült Államok
- Rare Disease Research Center Pediatrics, LLCAtlanta, Egyesült ÁllamokNo longer taking part
- Children's Hospital ColoradoAurora, Egyesült ÁllamokNo longer taking part
- Mid-Atlantic Epilepsy and Sleep Center - BethesdaBethesda, Egyesült ÁllamokNo longer taking part
- Children's of Alabama / University of Alabama at BirminghamBirmingham, Egyesült ÁllamokNo longer taking part
- University of North CarolinaChapel Hill, Egyesült ÁllamokNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, Egyesült ÁllamokNo longer taking part
- University of Missouri, Department of Child Health, Division of NeurologyColumbia, Egyesült ÁllamokNo longer taking part
- Duke University Hospital CenterDurham, Egyesült ÁllamokNo longer taking part
- Spectrum Health - Helen DeVos Children's HospitalGrand Rapids, Egyesült ÁllamokNo longer taking part
- Northwest Florida Clinical Research GroupGulf Breeze, Egyesült ÁllamokNo longer taking part
- Joe DiMaggio Children's HospitalHollywood, Egyesült ÁllamokNo longer taking part
- The University of Texas Health Science Center at HoustonHouston, Egyesült ÁllamokNo longer taking part
- Institute of Neurology and Neurosurgery at Saint BarnabasLivingston, Egyesült ÁllamokNo longer taking part
- University of California Los Angeles (UCLA).Los Angeles, Egyesült ÁllamokNo longer taking part
- Miami Children's Hospital - Nicklaus Children's HospitalMiami, Egyesült ÁllamokNo longer taking part
- Northwell Health - Neuroscience Institute at Great NeckNew Hyde Park, Egyesült ÁllamokNo longer taking part
- New York Medical CollegeNew York, Egyesült ÁllamokNo longer taking part
- NorthWell Health - Lennox Hill HospitalNew York, Egyesült ÁllamokNo longer taking part
- NYU Langone Comprehensive Epilepsy CenterNew York, Egyesült ÁllamokNo longer taking part
- Children's Hospital of Pittsburgh of UPMCPittsburgh, Egyesült ÁllamokNo longer taking part
- University of Rochester Medical CenterRochester, Egyesült ÁllamokNo longer taking part
- UCSD Rady's Children's HosptialSan Diego, Egyesült ÁllamokNo longer taking part
- Seattle Children's HospitalSeattle, Egyesült ÁllamokNo longer taking part
- MultiCare Institute for Research & InnovationTacoma, Egyesült ÁllamokNo longer taking part
- Pediatric Neurology, P.A.Winter Park, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Eisai Inc.
- Trial code
- NCT04572243
- Record updated
- 2025. október 8.
- Original description
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.Read full original descriptionShow less
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects With Dravet Syndrome
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.
Inclusion: Participants must meet all of the following criteria to be included in this study:; Male or female, age 2 years and older at the time of informed consent; Diagnosis of epilepsy with Dravet syndrome; Has at least 4 convulsive seizures during the 4 weeks of baseline; Current treatment with antiepileptic drugs must be stable for at least 4 weeks before screening, and be expected to remain stable throughout the study.
Exclusion: Use of lorcaserin within 4 weeks before screening, or any history of it being discontinued due to lack of efficacy or adverse reactions; Use of fenfluramine within 2 months before screening, any history of lack of fenfluramine efficacy, or any history of valvulopathy at baseline with history of fenfluramine use; Recent or concomitant use of serotonergic medications or monoamine oxidase inhibitors; Presence of progressive central nervous system disease other than Dravet syndrome; Participants who meet any of the following criteria will be excluded from this study:.